BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULMONARY HEMI-ARTERY SG

    MDR report key: 1622877 · Received March 2, 2010

    Report

    Report Number
    1063481-2010-00004
    Event Type
    Other
    Date Received
    March 2, 2010
    Report Date
    March 2, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    OHA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADD'L INFO WILL BE PROVIDED IN THE FOLLOW-UP REPORT. SYNERGRAFT PULMONARY HEMI-ARTERY IS REGULATED BY THE FDA AS A DEVICE AND THEREFORE, THIS REPORT IS BEING SUBMITTED TO (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE HOSP STATED THAT A PRE-IMPLANT CULTURE TAKEN FROM THE SYNERGRAFT PULMONARY HEMI-ARTERY TESTED POSITIVE FOR (B)(6) (SPECIES NOT REPORTED). ADDITIONALLY, THE HOSP REPORTED THAT ALL PT BLOOD CULTURES HAVE COME BACK NEGATIVE, AND THERE ARE NO SYSTEMIC SIGNS OR SYMPTOMS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONARY HEMI-ARTERY SG NON-VALVED HEART ALLOGRAFT OHA CRYOLIFE, INC. SGPH00

    Patients

    Seq Age Sex Outcome Treatment
    1